Philips CT systems patient support table may descend unexpectedly
Philips is recalling CT systems whose patient support tables may descend unexpectedly due to ball screw misalignment. The recall affects 285 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall receives a High (3) severity score because it involves a risk-of-harm medical device where unexpected patient table descent could cause injury. No illnesses or injuries have been reported, which per the rubric limits the score to a maximum of 3 despite the potential safety risk.
Plain-English summary
Philips is recalling specific CT systems because their patient support tables (treatment couches) may descend unexpectedly to the lowest position. The issue stems from ball screw misalignment that can occur after component replacement.
A misaligned ball screw in the table's support mechanism can cause the table to drop suddenly, rather than lowering in a controlled manner. This unexpected descent poses a risk of injury to patients positioned on the table during imaging procedures.
The recall affects 285 Philips Ingenuity CT systems distributed worldwide, including across the United States and more than 40 other countries. Specific model numbers affected are 728321, 728323, and 728326, with detailed serial number lists provided by the FDA.
Facilities using these CT systems should contact Philips North America LLC to determine if their equipment is among those affected by the recall. Users should not operate affected equipment until the issue has been resolved by the manufacturer.
The recalled product
- Product
- Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
- Manufacturer
- Philips North America Llc
- Hazard
- mechanical-failure
- unexpected-descent
- injury-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Model Number: 728321
- UDI-DI: 00884838059498
- Serial Numbers: 310033
- 310095
- 310098
- 333020
- 333135
- 52084
- 310005
- 310019
- 310030
- 310038
- 310050
- 310057
- 310053
- 310075
- 310126
- 310009
- 310101
- 310108
Distribution
Distributed nationwide across the United States.
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